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Abstract
Resumen
aim of this study was to analyze the variables determining the success
rates are not associated with other factors, such as sex, age, smoking
heavy smokers.
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Method
Procedure
A one-year follow-up was carried out, counting from the
point at which the patient gave up or should have given
up smoking, which for the patients meant a mean of 14
months of therapy. A total of 90% of the patients received
the multicomponent therapy in group format, while just
10% did so on an individual basis. The structure of the
therapy was the same for the group and individual formats.
In principle, all patients were assigned to the group mode,
the individual format being employed only in exceptional
cases (pregnant patients who could not wait for the start of
group programme, or people with difficulties for following
the group timetable). The therapy was implemented by the
same professionals (a psychologist and a lung specialist)
throughout the study. The multicomponent treatment
programme brings together all those strategies that have
shown themselves to be efficacious (Alonso-Perez et al.,
2014; Fiore, Jaen, Baker, Bailey, Benowitz, & Curri, 2009):
psychological treatments based on behavioural, cognitive,
motivational and relapse prevention techniques combined
with pharmacological treatment based on nicotine
replacement (Becoa & Mguez, 2008; Ranney et al.,
2006), bupropion and varenicline (Wu, Wilson, Dimoulas,
& Mills, 2006; Tinich & Sadler 2007; Cahill, Stevens, &
Lancaster 2014). Multicomponent therapy consists of three
phases: a) preparation, which involves psychoeducation
about addiction, motivation to quit, changing habits,
and monitoring of tobacco use with or without reduction
in six weekly 75-minte sessions; b) cessation, in which
pharmacological treatment is introduced where applicable
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Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez
and the therapists work on coping with the day the patient
gives up (D-Day), withdrawal syndrome and craving,
in four two-weekly 60-minute sessions; and c) relapse
prevention, following the models of Marlatt, Curry and
Gordon (1988) and Baer and Marlatt (1991), in 10 monthly
60-minute sessions.
The therapy involved no direct financial cost for the
patients, except for the pharmacological treatment, for
which they had to pay. All the patients received the same
psychological therapy and assignment to one type of
pharmacological treatment or another was in line with
clinical criteria, taking into account at each moment the
treatment that could most benefit the patient in accordance
with availability, previous experience, personal health
antecedents and pharmacological interactions with other
treatments he or she might be undergoing at that time.
Some patients decided not to take up the treatment, and
this group also includes those who did not receive treatment
because they dropped out of the programme before
beginning it (n=69).
Those patients that did not take up the treatment for
whatever reason remained in the study, and were contacted
by telephone or personally for the purpose of obtaining the
necessary follow-up data. The distribution of the patients
across the different treatment modes and retention up to
the 12-month follow-up are shown in detail in Figure 1.
Information on sociodemographic variables, heath
antecedents and smoking characteristics were obtained at
the first visit (which was always individual) based on the
patient interview and the data from the persons clinical
records. Information on how the patient was developing
and the drugs used was recorded in the first, third, sixth and
twelfth month after D-Day. All patients were contacted
Instruments
The objective measure of abstinence used was level of
carbon monoxide (CO) in expired air, or co-oximetry
(abstinent if CO6ppm) (Middleton & Morice, 2000). The
instrument employed for this purpose was a co-oximeter
(Bedfont Pico Smokerlyzer).
For the data analysis, the following variables were taken
into account: sex, age, educational level, living with other
smokers or not, occupation, number of cigarettes smoked
per day, years smoked, level of dependence according to
Fagerstrm Test (low dependence 4; medium=5; high 6),
psychiatric antecedents (yes/no), multicomponent therapy
(yes/no), pharmacological treatment (yes/no), and drug
used for smoking cessation.
Statistical analysis
The categorical variables are shown as absolute value
and relative frequency. The continuous variables are shown
with the mean and standard deviation. We calculated the
accumulated incidence of abstinence, both global and
according to multicomponent programme, at 1, 3, 6 and
12 months, together with its 95% confidence interval. The
variables associated with relapse at 12 months were examined
using bivariate and multivariate logistic regression models.
In the multivariate logistic regression model we introduced
the covariables found to be significant in the bivariate
analysis, or with evidence of their association. We used a
stepwise exclusion strategy controlled by the researcher. The
Baseline visit
N=314
Multicomponent programme
N=245
Psychological treatment
N=81
Abstinent
N=1
Not abstinent
N=68
Abstinent
N=13
Not abstinent
N=68
39
Abstinent
N=61
Not abstinent
N=103
raw and adjusted odds ratios (OR) and the 95% confidence
intervals (CI 95%) were calculated. Statistical significance
level was bilateral 5% (p<0.05).
The programs used in the statistical analysis were IBM
SPSS Statistics for Windows v.22 (IBM Corporation,
Armonk, New York, USA) and Stata v.10 (StataCorp LP,
College Station, Texas, USA).
Results
Table 1.
Baseline characteristics of participants (n=314)
Mean age of the patients was 48.5 years; 61.8% were men,
61.9% had only elementary education and 32.6% were skilled
workers or professionals. As regards smoking characteristics,
50.3% lived with other smokers, 34.4% had been smoking
for 35 years or more, 48.2% smoked 21 or more cigarettes
per day, and 68.8% had high nicotine dependence (score
6) according to the Fagerstrm Test. Furthermore, 57.1%
of the patients had made two or more previous attempts to
quit smoking, 85% had been referred to the programme
from other hospital departments where they were being
treated for illnesses associated with smoking, and 58% had
psychiatric antecedents (Table 1).
Of the total 314 patients, we included all those who during
the studied period put their names down on the waiting list
and came to the first appointment when called; of these, 69
dropped out of the programme before the first session of
multicomponent therapy and the remaining 245 began the
multicomponent therapy (Figure 1). Of these 245 patients,
81 did not receive the pharmacological treatment, on their
own or the doctors decision (n=29) or because they gave up
the therapy before completing the first phase (n=52).
Abstinence for the whole sample was 50.3% at the onemonth follow-up, 38.5% at three months, 29.0% at six
months and 23.9% at 12 months. Patients who received
psychological and pharmacological treatment obtained the
highest abstinence rates at all the follow-up points, showing an
abstinence rate at 12 months of 37.2%, followed by those who
n=(%)
Mean age [standard deviation]
48,5[12,1]
Sex
Man
Woman
194 (61,8)
120 (38,2)
Educational level
Primary
Secondary
University
192 (61,9)
63 (20,3)
55 (17,7)
156 (49,7)
158 (50,3)
Years smoked
20
21-35
> 35
68 (21,7)
138 (43,9)
108 (34,4)
Fagerstrm Test
< 4 Low
4-5 Medium
6 High
27 (8,6)
71 (22,6)
216 (68,8)
Psychiatric antecedents
No
Yes
132 (42,0)
182 (58,0)
Multicomponent programme
Neither psychological nor pharmacological
treatment
Psychological treatment
Psychological and pharmacological treatment
69 (22,0)
81 (25,8)
164 (52,2)
84 (51,2)
30 (18,3)
50 (30,5)
Table 2.
Abstinence (global and according to multicomponent programme) at 1, 3, 6 and 12 months
n
1 montha
3 monthsa
6 monthsa
12 monthsa
314
50,3 (44,6-56,0)
38,5 (33,1-44,2)
29,0 (24,0-34,3)
23,9 (19,3-29,0)
69
2,9 (0,4-10,1)
Psychological treatment
81
27,2 (17,9-38,2)
23,5 (14,8-24,2)
16,0 (8,8-25,9)
16,0 (8,8-25,9)
164
81,7 (74,9-87,3)
61,6 (53,7-69,1)
47,0 (39,1-54,9)
37,2 (29,8-45,1)
84
83,3 (73,6-90,6)
61,9 (50,7-72,3)
50,0 (38,9-61,1)
44,0 (33,2-55,3)
Bupropion
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83,3 (65,3-94,4)
70,0 (50,6-85,3)
50,0 (31,3-68,7)
36,7 (19,9-53,9)
Varenicline
50
78,0 (64,0-88,5)
56,0 (41,3-70,0)
40,0 (26,4-54,8)
26,0 (14,6-40,3)
Global
According to multicomponent programme
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Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez
Table 3.
Risk factors for relapse at 12 months. Bivariate analysis.
Abstinencea
n=75
Relapsesa
n=239
p value
50,7[12,0]
47,8[12,0]
0,98 (0,96-1,00)
0,068
Sex
Man
Woman
51 (26,3)
24 (20,0)
143 (73,7)
96 (80,0)
1b
1,43 (0,82-2,47)
0,205
Educational level
Primary
Secondary
University
35 (18,2)
23 (36,5)
16 (29,1)
157 (81,8)
40 (63,5)
39 (70,9)
1b
0,39 (0,21-0,73)
0,54 (0,27-1,08)
0,003
0,082
47 (30,1)
28 (17,7)
109 (69,9)
130 (82,3)
1b
2,00 (1,18-3,41)
0,011
Years smoked
> 35
21-35
<= 20
32 (29,6)
31 (22,5)
12 (17,6)
76 (70,4)
107 (77,5)
56 (82,4)
1b
1,45 (0,82-2,58)
1,96 (0,93-4,15)
0,202
0,077
Fagerstrm Test
<4 Low
4-5 Medium
<= 6 High
7 (25,9)
24 (33,8)
44 (20,4)
20 (74,1)
47 (66,2)
172 (79,6)
1b
0,68 (0,25-1,85)
1,37 (0,54-3,44)
0,455
0,505
Psychiatric antecedents
No
Yes
36 (27,3)
39 (21,4)
96 (72,7)
143 (78,6)
1b
1,38 (0,82-2,32)
0,231
1 (1,4)
13 (16,0)
61 (37,2)
68 (98,6)
68 (84,0)
103 (62,8)
1b
0,08 (0,01-0,60)
0,02 (0,003-0,18)
0,015
< 0,001
37 (44,0)
11 (36,7)
13 (26,0)
47 (56,0)
19 (63,3)
37 (74,0)
1b
1,36 (0,58-3,21)
2,24 (1,04-4,81)
0,483
0,039
Multicomponent programme
Neither psychological nor pharmacological
treatment
Psychological treatment
Psychological and pharmacological treatment
Nicotine replacement therapy
Bupropion
Varenicline
a
Table 4.
Risk factors for relapse at 12 months.
Multivariate analysis.
p value
Age
0,98 (0,96-1,01)
0,169
Sex
Man
Woman
1a
1,36 (0,69-2,66)
0,371
Educational level
Primary
Secondary
University
1a
0,36 (0,18-0,73)
0,41 (0,19-0,89)
0,005
0,024
1a
2,03 (1,12-3,68)
0,020
1a
0,06 (0,01-0,51)
0,010
0,02 (0,003-0,17)
<0,001
Multicomponent programme
Neither psychological nor
pharmacological treatment
Psychological treatment
Psychological and
pharmacological treatment
a
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Discussion
42
Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez
following psychological therapy after the third smokingfree month is effective for the maintenance of abstinence
(Hajek et al., 2013). Likewise, various reviews have shown
how group therapy, cognitive-behavioural therapy and
interventions with intensive follow-up are more efficacious
in the long term (Bauld et al., 2010; Hall, Humfleet, Muoz,
Reus, Robbins, Prochaska, 2009).
We observed a clear advantage of nicotine replacement
therapy compared to varenicline. Given that this was a
descriptive study, it should be borne in mind that there
may be bias in relation to the selection of pharmacological
options, since they were not assigned randomly; hence,
we cannot draw the kinds of causal conclusions that could
be drawn from a study with experimental design. These
differences may be due to the fact that greater efficacy of
varenicline for reducing symptoms of craving (Stapleton
et al., 2008) would hinder the learning of coping strategies
for craving on the part of these patients. This is why after
the end of the pharmacological treatment we see a higher
relapse rate. Since we are talking about patients with serious
difficulties for quitting smoking, there may be an influence
of poor ability to apply relapse-prevention strategies. If this
were indeed the case, nicotine replacement therapy would
emerge as the most appropriate pharmacological treatment
for multicomponent therapy interventions with these types
of patients, while varenicline would be more suitable for
patients who had not previously tried and failed to quit,
who would not be followed-up after the pharmacological
treatment, or who did not receive psychological treatment,
though this hypothesis would need to be tested with specially
designed studies.
It would be useful to analyze therapy adherence according
to the characteristics of participants who completed
the treatment, since this would provide information on
predictors of adherence to multicomponent therapy and
would help in the consideration of possible aspects to
improve with a view to increasing it.
The main limitation of the present study concerns the
time dimension. The fact of the sample being recruited over
a long period (9 years) means that socio-cultural variables
(e.g., legislative changes with regard to the prohibition of
smoking in public spaces, changes in societys perception of
the risks involved in smoking) could be having an effect that
we have not controlled for. Thus, it may be that the 2005
legislation restricting smoking in public had some influence
on peoples motivation to give up smoking. On the other
hand, though, the fact that the smokers in our sample had
homogeneous characteristics (high level of dependence,
many with previous pathologies, several attempts to quit)
brings some correctional elements, so that this aspect does
not influence the results as much as it would in a study with
the general population. Another limitation is not having
a record of the exact date of relapse, as this prevents us
from knowing whether a patient starts smoking again and
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Conflicts of interests
The authors declare that there are no conflicts of interests.
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Acknowledgements
Thanks to Anna Arnau, Rosa Cobacho, Joan Taberner
and Alejandro Gella for their help at different stages of the
study.
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Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez
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